GAMP – Good Automated Manufacturing Practices

Hello good people of the world! What, another acronym?! Yes, we love ’em!

GAMP = Good Automated Manufacturing Practices is a term coined by ISPE and their associated JETT consortium. GAMP focuses on automation and control systems, i.e. computer software and hardware. GAMP is one response to FDA’s 21CFR11.

One of GAMP’s most recognizable contributions to automation validation is the so-called V-model, which takes many forms but perhaps in it’s simplest is below:

Another highlight from the guidance is the categorization of software, which looks something like: